The complaint centers on disclosures regarding the company's manufacturing vendor, which Unicycive described as having resolved critical deficiencies. Investors argue that leadership failed to verify these claims before promoting them to the market. The fallout became apparent on June 30, 2026, when the company received a second Complete Response Letter from the FDA. Following the announcement, UNCY shares plummeted from $7.70 to $4.69 in a single session, representing a 39.1% decline on heavy trading volume.
In section Releases
Unicycive Therapeutics Faces Class Action Over FDA Compliance Claims
A federal securities class action alleges that Unicycive Therapeutics misled investors by claiming a third-party manufacturer had made significant progress toward FDA compliance without ever conducting an internal audit. The lawsuit targets CEO Shalabh Gupta and CFO John Townsend, citing personal liability for disclosures made between December 2025 and June 2026.
Legal counsel for the plaintiffs, Joseph E. Levi, asserts that the executives bear personal responsibility for the accuracy of these statements under Sarbanes-Oxley certifications. The suit, filed in the Northern District of California, seeks to hold Gupta and Townsend accountable under Section 20(a) of the Securities Exchange Act, which addresses control person liability. Investors who purchased stock during the class period have until November 2, 2026, to apply for lead plaintiff status.
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